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Quality Management Maturity: The Strategic Vision for Biopharmaceutical Excellence

David Doleski
Prudence Edwards
Joseph Olewinski
Quality Management Maturity

To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive and vigilant approach that is science and risk-based, incorporating continuous improvement.

Quality management in biopharmaceuticals has emphasized compliance and control – which is expected given the highly regulated nature of the industry. However, quality management is most effective when it is intentionally designed into every facet of production, shifting the mindset from reactive measures to proactive excellence.

2024 ISPE Biotechnology Conference

Quality management maturity is a hot topic in the pharmaceutical industry, triggered by the US Food and Drug Administration’s (US FDA’s) creation of a program to promote quality management maturity (QMM) at drug manufacturing establishments. This initiative provides regulatory incentives for organizations to extend beyond current good manufacturing practice (CGMP) requirements to support a more reliable drug supply chain, reduce quality failures, and foster proactive continual improvement. The US FDA’s Center for Drug Evaluation and Research (CDER) has established principles of quality management that are pertinent to all biomanufacturing facilities, especially for biological products with the increased scale of commercial manufacturing. To complement the FDA’s QMM program, several industry bodies have developed industry-led approaches to continuous improvement in quality management, including ISPE’s Advancing Pharmaceutical Quality (APQ) program.

At the 2024 ISPE Biotechnology Conference, Track 2 will serve as a platform for exploring “Quality Culture within the Quality Management Maturity (QMM) Framework” within the industry and the ways regulators envision a future in which quality is not just a compliance requirement, but a driver for more reliable supply of safe and effective drugs for patients, instilled across all facets of daily operations.

Speakers and related sessions include:

Commitment to Quality Through Management Maturity

Presented by: 

This session will provide a deep dive into the concepts proposed by the US FDA. Miller will focus on the practice areas highlighted in the US FDA’s QMM prototype. This integrates an ICH-based framework to support the industry’s assessment and positively impact overall performance.

Enterprise Maturity

Presented by: 

Explore an example of the QMM model that involves the delineation of interdependencies across leadership ability, systems, risk integration, and design quality.

Quality Culture in the Pharmaceutical Industry

Presented by: 

Dorset Quality Services (DQS) Ltd

Investigate the impact of poor quality culture on the safety and integrity of manufactured products. Apply strategies to implement an improved quality culture throughout the organization at a behavioral level.

Quality Maturity Model Framework Construction is an Art

Presented by: 

Understand the importance of having the right foundation for quality maturity. This session will focus on key fundamentals of a quality management system and the relationship between leadership commitment and quality culture.

A Scientific Perspective on Quality Management Maturity

Presented by: 

Results from a two-year study will be showcased in this presentation, which will focus on the role of leadership in shaping a quality culture and the elements characterizing a good quality culture. Presenters will compare regulatory expectations with the industry’s current understanding.

The Role of Leaders in Quality Culture

Presented by: 

Smith will provide examples of how leaders implement quality management system program elements and exhibit behaviors that support robust quality culture throughout the rest of the organization.

ISPE Advancing Pharmaceutical Quality (APQ) Program

Presented by: 

Ta will present an overview of the APQ program—its basis in ICH Q10, the assess, aspire, act, advance framework, and the guide series. The ISPE APQ program aligns with international ICH Q10 standards and provides a practical framework for organizations to enhance the effectiveness of their pharmaceutical quality system (PQS). It is an industry-led initiative that complements the US FDA’s vision and empowers companies to assess, aspire, act, and advance their level of quality management maturity.

Ta’s 15-minute session will serve as a precursor to a related ISPE training course for those seeking to deepen their understanding and application of QMM principles. The Advancing Pharmaceutical Quality (APQ) Quality Management Maturity Training Course will take place directly following the conference, 19-20 June. The course guides participants through structured tools using industry best practices for assessing and advancing quality within their organizations. 

The Track 2 leads and the extended 2024 ISPE Biotechnology Conference International Program Committee look forward to a thought-provoking and inspiring discussion on QMM at the 2024 ISPE Biotechnology Conference in Boston, Massachusetts, USA, June 17-18.

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